Therapie最新文献

{"title":"[Early non-compliance with oral anticancer drugs, a clinical pharmacy as key issue in onco-senology].","authors":"Fanny Leenhardt, Pauline Ares, Alma Nicolai, Cécile Corbinais, Marie Viala, Véronique d'Hondt, François Jouvet, Frédéric Pinguet","doi":"10.1016/j.therap.2025.06.001","DOIUrl":"10.1016/j.therap.2025.06.001","url":null,"abstract":"<p><strong>Introduction: </strong>The assessment of adherence is necessary to ensure therapeutic compliance, particularly with oral anti-cancer drugs (OACs). Already easily implemented, the nationally validated GIRERD questionnaire seems incomplete for assessing adherence. We set out to study and characterize adherence in a cohort of patients treated with OACs, using 2 questionnaires.</p><p><strong>Material and methods: </strong>The evaluation was carried out in patients treated with OAC using the GIRERD questionnaire, composed of 6 items, and an institutional questionnaire consisting of 7 items; with a common gradation based on that of the GIRERD score. These questionnaires were submitted within the first 3 months of ribociclib (OAC) initiation, in women with metastatic hormone-dependent breast cancer.</p><p><strong>Results: </strong>Of the 50 evaluable patients, around 60% had a score above 0 (poorly observant [PO]+unobservant [UO]) according to the 2 questionnaires during this study. UO patients represent 6% according to the GIRERD score and 16% according to the institutional score. The main causes of non-adherence were late dosing (21/50) and forgetting to take the ACO when travelling (13/50). Fifty-four percent of patients who had an aid to help them take their ACO (pillbox, etc.) proved to be unobservant.</p><p><strong>Discussion: </strong>More than half of patients had at least one non-adherence event in the first 3 months of OAC, indicating a need to secure the initiation of these treatments. Compliance must be assessed using appropriate tools. Finally, the institutional score intercepts more outright non-compliance, whereas the GIRERD score would underestimate non-compliance in our cohort.</p><p><strong>Conclusion: </strong>More than half the patients in our cohort appear to be poorly compliant at an early stage, whatever the assessment score. This assessment of compliance constitutes a feasibility study for the use of our questionnaire in routine clinical monitoring of patients receiving an OAC.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retinal venous occlusion in drug-induced lupus.","authors":"Adrien Blanc, Charles Khouri, Laurence Bouillet, Christophe Chiquet","doi":"10.1016/j.therap.2025.05.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.05.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144294965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[The French IRB Study: Qualification of research by ethics committees].","authors":"Charles-Hervé Vacheron, Arnaud Friggeri, Maxime Lambert, Laura Shoonjans, Philippe Amiel","doi":"10.1016/j.therap.2025.05.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.05.002","url":null,"abstract":"<p><strong>Objectives: </strong>In France, the \"Research investigations involving human subjects\" (RIPH), defined in the Public Health Code, are reviewed by \"committees for the protection of persons\" (CPP) established by law. Other research studies in health are evaluated conducted by \"research ethics committees\" (CER) that can be established by research institutions (institutes, hospitals, universities, etc.) without a defined legal framework. The qualification of the research as RIPH or \"non-RIPH\" (RNIPH) determines the evaluation pathway - mandatory legal or extra-legal. Our objective was to describe the performance of CERs and CPPs in qualifying research projects as RIPH or RNIPH, the qualification standard used being the \"Guide to the qualification of health research\", an Inserm reference published in 2021.</p><p><strong>Methods: </strong>Since the list of CPPs was already known, universities, university hospitals, and learned societies in medical specialties were contacted to find out if they housed a CER. Between 29/01/2024 and 29/02/2024, all documented CPPs and CERs were asked to participate in the study. If accepted, an email was sent to members with an online questionnaire proposing four cases to be qualified, either RIPH or non-RIPH. The cases were taken from the examples provided by the Inserm guide, which also served as a reference for assessing the responses. The analysis of the responses was carried out individually and at the level of each participating committee.</p><p><strong>Results: </strong>Thirty-five (35) centers, out of the 110 contacted, participated, producing 175 individual responses collected. The number of members per committee was 18 [12-23]. The response rate per committee was 27% [14-47]. Regarding the members' responses, the qualification was consistent with that of the Inserm guide in 79% (138), 62% (108), 66% (116), and 61% (106) of cases. At the committee level, a wide disparity between the different centers was documented, without notable differences between CER and CPP.</p><p><strong>Conclusion: </strong>A significant heterogeneity in the qualification of research was noted between the different committees, unrelated to the type of structure (CER or CPP). Information and training systems, aimed at all types of committees, should be encouraged to standardize the research qualification step.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144187995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patients under treatment for sarcoidosis reported adherence issues and would welcome personalized pharmaceutical care: Results from survey online.","authors":"Cléa Dubrou, Dorian Protzenko, Aurélie S Leroyer, Raphael Cauchois, Gilles Kaplanski, Guillaume Hache","doi":"10.1016/j.therap.2025.05.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.05.001","url":null,"abstract":"<p><p>Sarcoidosis is an immune-inflammatory condition marked by significant health disparities. Around 50% of individuals diagnosed with sarcoidosis need long-term or even lifelong treatment to halt the progression of the disease. Recent guidelines, primarily targeting pulmonary sarcoidosis, have been proposed. Despite this, reports on medication adherence in sarcoidosis are scarce, and pharmaceutical care is rarely incorporated into patient-centered treatment strategies. In our study, we conducted a survey through social media (n=157) and discovered that 79% of participants were either slightly or not at all adherent to their medication regimen, according to the Girerd score. The primary goal of this project is to pinpoint the factors influencing non-adherence among sarcoidosis patients. We identified that treatment involving corticosteroids or corticosteroid-sparing drugs, coupled with factors like age and pulmonary localization, are linked to poorer adherence outcomes. Moreover, patients demonstrating poor adherence showed a readiness to engage in personalized pharmaceutical care.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144133244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy","authors":"Isabelle Lacroix ,&nbsp;Anthony Caillet ,&nbsp;Laurane Delteil ,&nbsp;Hadjer Ameur ,&nbsp;Nassima Padelli ,&nbsp;Caroline Hurault-Delarue ,&nbsp;Judith Cottin","doi":"10.1016/j.therap.2024.06.003","DOIUrl":"10.1016/j.therap.2024.06.003","url":null,"abstract":"<div><div><span><span>The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the </span>health status<span><span> of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported </span>adverse reactions over time. We conducted a prospective study using an online questionnaire. Women vaccinated during pregnancy who wanted to participate were asked to complete an inclusion questionnaire (dates of pregnancy and </span></span>vaccination<span> COVID-19, etc.), a questionnaire on the potential occurrence of adverse reactions (time of onset, type of adverse reaction, etc.) of the vaccination, sent 1 month after the injection, and a final questionnaire on the outcome of the pregnancy and the health status of the child. A total of 938 women were prospectively included in this first French study. A total of 132 women reported having had at least 1 adverse reaction following vaccination during pregnancy (14.1%), including few ‘serious’ adverse reaction (5.3%). There were no signals of adverse reactions during continuous monitoring. Among the 938 pregnant women, 22.4% received the vaccination COVID-19 during the first trimester, 64.2% during the second and 33.4% during the third trimester (some women have had several injections in different trimesters). Among the 938 women, 4.3% developed gestational hypertension<span><span> and 13.9% diabetes; 3.3% had intrauterine growth restriction and 7.8% threatened </span>preterm delivery. These rates are comparable to those observed in the French general population. Among live births, the rate of preterm birth was 5.1%. We reported a prevalence of major malformations of 3.9%, which is comparable to that reported by European Surveillance of Congenital Anomalies (EUROCAT), with a rate of 3.5% of major malformations in the general population of mainland France. In conclusion, our study did not demonstrate any particular safety signals in the event of vaccination with a Covid-19 vaccine during pregnancy.</span></span></div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 271-278"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141601799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Elexacaftor/tezacaftor/ivacaftor induced liver enzymes abnormalities in breastfed infants: A series of 3 cases","authors":"Sandrine Bergeron ,&nbsp;Camille Audousset ,&nbsp;Gurvan Bourdon ,&nbsp;Charles Garabedian ,&nbsp;Sophie Gautier","doi":"10.1016/j.therap.2024.08.001","DOIUrl":"10.1016/j.therap.2024.08.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 341-343"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hépatite aiguë cytolytique suivie d’œdèmes associés à l’utilisation des neuroleptiques : à propos d’un cas et revue de la littérature","authors":"Fatma Guermazi ,&nbsp;Rabeb Jbir ,&nbsp;Imen Bouaziz ,&nbsp;Rim Atheymen ,&nbsp;Dorra Mnif ,&nbsp;Nourelhouda Ben Ali ,&nbsp;Kamilia Ksouda ,&nbsp;Khaled Zghal ,&nbsp;Imen Baati ,&nbsp;Jawaher Masmoudi","doi":"10.1016/j.therap.2024.11.004","DOIUrl":"10.1016/j.therap.2024.11.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 348-351"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effets indésirables de l’association tezacaftor/ivacaftor/elexacaftor pouvant mener à un arrêt de traitement : à propos d’une série de 10 cas","authors":"Elora Blaisonneau ,&nbsp;Brendan Le Daré ,&nbsp;Marion Mercerolle ,&nbsp;Astrid Bacle ,&nbsp;Louise Triquet ,&nbsp;Marie-Noëlle Osmont ,&nbsp;Chantal Belleguic ,&nbsp;Elisabeth Polard","doi":"10.1016/j.therap.2024.06.005","DOIUrl":"10.1016/j.therap.2024.06.005","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Les modulateurs des canaux &lt;em&gt;cystic fibrosis transmembrane regulator&lt;/em&gt; (CFTR) (ivacaftor, lumacaftor, tezacaftor et elexacaftor) constituent une avancée majeure dans la prise en charge de la mucoviscidose. Cependant, peu de données existent quant au profil de sécurité de ces médicaments en vie réelle, en particulier sur les effets indésirables pouvant conduire à leur arrêt. L’objectif de cette étude est de décrire les caractéristiques et l’évolution des effets indésirables de l’association tezacaftor/ivacaftor/elexacaftor ayant mené à un arrêt et rapportés au Centre régional de pharmacovigilance (CRPV) de Rennes (France).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériels et méthodes&lt;/h3&gt;&lt;div&gt;Une étude rétrospective a été menée de décembre 2021 à mai 2023, portant sur les cas d’arrêt de l’association tezacaftor/ivacaftor/elexacaftor en raison de la survenue d’un ou plusieurs effets indésirables, cas rapportés au CRPV de Rennes (France).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Dix cas d’arrêt de médicament ont été rapportés au CPRV de Rennes (6 femmes/4 hommes). Les effets indésirables concernaient majoritairement les troubles neuropsychiatriques (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;6), suivis des perturbations du bilan hépatique (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;2), des troubles otorhinolaryngologiques (ORL) (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;1) et des troubles digestifs (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;1). La durée moyenne de traitement à l’arrêt était de 339,8 [39–668] jours. Le médicament a été réintroduit chez 7 patients en moyenne 48,7 [7–123] jours après l’arrêt, avec une adaptation de posologie (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;4) consistant en une inversion des moments de prise ou une diminution des doses journalières, avec ou sans succès sur la symptomatologie des effets indésirables en fonction des cas.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Cette petite série de cas suggère que les effets indésirables neuropsychiatriques pourraient survenir plus fréquemment qu’initialement décrit après l’instauration de tezacaftor/ivacaftor/elexacaftor, et devraient faire l’objet d’un dépistage et d’un suivi attentifs. Des modifications de la posologie ou du rythme d’administration peuvent être envisagées pour les patients souffrant de ces effets indésirables. De plus amples études de pharmacovigilance seraient nécessaires pour mieux connaître les profils d’effets indésirables des « caftors », leurs éventuels facteurs de risque d’apparition et l’impact de l’adaptation des modalités de prise.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Cystic fibrosis transmembrane regulator (CFTR) channel modulators (ivacaftor, lumacaftor, tezacaftor and elexacaftor) represent a major advance in the management of cystic fibrosis. However, few data are available on the real-life safety profile of these medications, in particular on adverse events that may lead to their discontinuation. The aim of this study is to describe the characteristics and evolution of adverse reactions to the t","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 279-293"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141690204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adalimumab-induced myoclonus: A potential adverse drug reaction?","authors":"Yasmine Salem Mahjoubi ,&nbsp;Israa Dahmani ,&nbsp;Fatma Zgolli ,&nbsp;Widd Kaabi ,&nbsp;Sarrah Kastalli ,&nbsp;Imen Aouintin ,&nbsp;Sihem El Aidli","doi":"10.1016/j.therap.2024.12.006","DOIUrl":"10.1016/j.therap.2024.12.006","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 356-358"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adagrasib-induced photodistributed hyperpigmentation: Two case reports and pathogenetic hypothesis","authors":"Julien Lebled ,&nbsp;Jean-Paul Claudel ,&nbsp;Marie-Sarah Agier ,&nbsp;Laurent Plantier ,&nbsp;Bérenger Largeau ,&nbsp;Annie-Pierre Jonville-Bera","doi":"10.1016/j.therap.2024.12.014","DOIUrl":"10.1016/j.therap.2024.12.014","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 333-336"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}